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Most recent job postings at WhoSampled
via LinkedIn
posted_at: 8 days agoschedule_type: Full-time
COMPANY OVERVIEW:
Sampled SMART Labs mission is to be the lab behind every transformative health innovation. Our vision is a world where we make it faster and easier for health innovators to improve human health and to be the leading global integrated analytical biorepository...
We are committed to delivering flexible and tailored solutions that exceed our customers’ performance, reliability, delivery and quality expectations through a culture
COMPANY OVERVIEW:
Sampled SMART Labs mission is to be the lab behind every transformative health innovation. Our vision is a world where we make it faster and easier for health innovators to improve human health and to be the leading global integrated analytical biorepository...
We are committed to delivering flexible and tailored solutions that exceed our customers’ performance, reliability, delivery and quality expectations through a culture which focuses on quality, empowerment, continuous improvement and best practices. In this unique role as Head of Regulatory and Quality Assurance, you will have the opportunity to personally impact how we consistently achieve these commitments.
POSITION SUMMARY:
Reporting to the Chief Scientific Officer, the Head of Regulatory Affairs and Quality Assurance is responsible for oversight of the Sampled Regulatory, Quality and Environmental, Health and Safety programs of the Sampled business to ensure compliance with state and federal laws, GxP and industry guidance documents.
In this senior global role, the postholder will be the primary advisor for Regulatory requirements to the Executive Team, and will develop plans for regulatory submissions consistent with the Sampled Strategic Plan. This role is responsible for implementing policies, procedures, and protocols which result in attaining the goals of the Sampled Strategic Plan as well as the ongoing development of robust and compliant Quality and EHS Systems.
RESPONSIBILITIES:
• Participate in the development of the Sampled Strategic Plan and be primary adviser for Regulatory requirements to the Executive Team.
• Assess the Sampled Strategic Plan and determine the necessary regulatory efforts needed to achieve the plan and develop the plans to meet all regulatory notifications, submissions, etc.
• Prepare and submit all required Regulatory submissions.
• Responsible to planning, conducting and leading effective and efficient regulatory inspections and audits.
• Maintain all required licensure (state/local, Federal and international)
• Ensure the implementation and continuous improvement of robust and compliant Quality and EHS Systems:
Ensure an effective CAPA system
Ensure Design Control process is consistent with the 21 CFR Part 820.30
Develop and maintain process for supplier audits
Oversee the team responsible for leading, facilitating, and preparing client audits and ensure successful audits.
Monitor client audit responses and corrective actions timeliness and effectiveness.
Implement and maintain a program for Management Review that includes operational metrics tracking and trending.
Monitor the internal audit program and the effectiveness of the measures and the corrective actions.
• Be an effective leader providing support, training, guidance and mentorship to direct reports. Overall, the global function has approximately 12 staff globally in Quality Assurance, Clinical QC/QA and EHS, including 4 direct reports. Ensure effective communication cascade through area of responsibility.
• Member of the Sampled Core Management Team and Global Senior Leadership Team.
• Maintain working knowledge of applicable regulations and standards affecting company sites and global functions
• Be an active champion and role model of the Sampled Core Values: Strive to delight our clients, move innovation forward, Accelerate your business, Rise together as a team, Transcend what is possible.
• Support an environment of continuous improvement with an emphasis on relationship management, shared accountability, and open communication.
• Effectively identify improvement techniques and tools to improve Quality and compliance systematically.
POSITION REQUIREMENTS:
• Bachelor's Degree in a science discipline, Masters Degree preferred.
• Significant experience, ideally 15+ years, in Biotechnology, Pharmaceutical or Medical Device industry, including extensive experience in the areas of Regulatory Affairs and Quality Assurance.
• Experience with 510K submissions.
• Knowledge of Biologics, Cell Therapy and/or Gene Therapy, experience a plus
• In depth knowledge of all applicable state/local, Federal (CLIA, US FDA regulations 21 CFR 210, 211, 21 CFR 820, 21 CFR Part 58, 21 CFR Part 1271) and international (UKAS, HFEA, etc.) regulations
• Working knowledge of ISO standards (ISO 9001, ISO 13458, ISO 15189)
• Experience leading and facilitating audits.
• Excellent root cause analysis/CAPA, problem solving, and analytical skills. Able to think creatively.
• Excellent leadership skills and ability to work collaboratively at all levels across the organization.
• Strong communication and interpersonal skills, able to effectively lead and manage change and create buy-in to a Quality & Safety driven culture throughout the organization.
• Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
• Good level of commercial acumen.
• Demonstrated high level of initiative and ability to work independently, proven ability to work effectively with teams.
• Competent using, implementing and developing Quality Assurance software systems.
• Proficient using Microsoft Office applications Show more details...
Sampled SMART Labs mission is to be the lab behind every transformative health innovation. Our vision is a world where we make it faster and easier for health innovators to improve human health and to be the leading global integrated analytical biorepository...
We are committed to delivering flexible and tailored solutions that exceed our customers’ performance, reliability, delivery and quality expectations through a culture which focuses on quality, empowerment, continuous improvement and best practices. In this unique role as Head of Regulatory and Quality Assurance, you will have the opportunity to personally impact how we consistently achieve these commitments.
POSITION SUMMARY:
Reporting to the Chief Scientific Officer, the Head of Regulatory Affairs and Quality Assurance is responsible for oversight of the Sampled Regulatory, Quality and Environmental, Health and Safety programs of the Sampled business to ensure compliance with state and federal laws, GxP and industry guidance documents.
In this senior global role, the postholder will be the primary advisor for Regulatory requirements to the Executive Team, and will develop plans for regulatory submissions consistent with the Sampled Strategic Plan. This role is responsible for implementing policies, procedures, and protocols which result in attaining the goals of the Sampled Strategic Plan as well as the ongoing development of robust and compliant Quality and EHS Systems.
RESPONSIBILITIES:
• Participate in the development of the Sampled Strategic Plan and be primary adviser for Regulatory requirements to the Executive Team.
• Assess the Sampled Strategic Plan and determine the necessary regulatory efforts needed to achieve the plan and develop the plans to meet all regulatory notifications, submissions, etc.
• Prepare and submit all required Regulatory submissions.
• Responsible to planning, conducting and leading effective and efficient regulatory inspections and audits.
• Maintain all required licensure (state/local, Federal and international)
• Ensure the implementation and continuous improvement of robust and compliant Quality and EHS Systems:
Ensure an effective CAPA system
Ensure Design Control process is consistent with the 21 CFR Part 820.30
Develop and maintain process for supplier audits
Oversee the team responsible for leading, facilitating, and preparing client audits and ensure successful audits.
Monitor client audit responses and corrective actions timeliness and effectiveness.
Implement and maintain a program for Management Review that includes operational metrics tracking and trending.
Monitor the internal audit program and the effectiveness of the measures and the corrective actions.
• Be an effective leader providing support, training, guidance and mentorship to direct reports. Overall, the global function has approximately 12 staff globally in Quality Assurance, Clinical QC/QA and EHS, including 4 direct reports. Ensure effective communication cascade through area of responsibility.
• Member of the Sampled Core Management Team and Global Senior Leadership Team.
• Maintain working knowledge of applicable regulations and standards affecting company sites and global functions
• Be an active champion and role model of the Sampled Core Values: Strive to delight our clients, move innovation forward, Accelerate your business, Rise together as a team, Transcend what is possible.
• Support an environment of continuous improvement with an emphasis on relationship management, shared accountability, and open communication.
• Effectively identify improvement techniques and tools to improve Quality and compliance systematically.
POSITION REQUIREMENTS:
• Bachelor's Degree in a science discipline, Masters Degree preferred.
• Significant experience, ideally 15+ years, in Biotechnology, Pharmaceutical or Medical Device industry, including extensive experience in the areas of Regulatory Affairs and Quality Assurance.
• Experience with 510K submissions.
• Knowledge of Biologics, Cell Therapy and/or Gene Therapy, experience a plus
• In depth knowledge of all applicable state/local, Federal (CLIA, US FDA regulations 21 CFR 210, 211, 21 CFR 820, 21 CFR Part 58, 21 CFR Part 1271) and international (UKAS, HFEA, etc.) regulations
• Working knowledge of ISO standards (ISO 9001, ISO 13458, ISO 15189)
• Experience leading and facilitating audits.
• Excellent root cause analysis/CAPA, problem solving, and analytical skills. Able to think creatively.
• Excellent leadership skills and ability to work collaboratively at all levels across the organization.
• Strong communication and interpersonal skills, able to effectively lead and manage change and create buy-in to a Quality & Safety driven culture throughout the organization.
• Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
• Good level of commercial acumen.
• Demonstrated high level of initiative and ability to work independently, proven ability to work effectively with teams.
• Competent using, implementing and developing Quality Assurance software systems.
• Proficient using Microsoft Office applications Show more details...
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